Occluder with access passage and closure thereof

ABSTRACT

The present disclosure is directed to embodiments of an occlusive medical device including a frame and at least one closure coupled to the frame. The frame includes a distal annular flange having a radially outer surface and a radially inner surface, a proximal annular flange having a radially outer surface and a radially inner surface, and a waist portion extending between and connecting the distal annular flange to the proximal annular flange. The radially inner surface of the distal annular flange, the waist member, and the radially inner surface of the proximal annular flange define an unobstructed passageway through the frame. The at least one closure is configured to close the passageway to: (i) provide an occlusive effect, and (ii) enable subsequent access through the passageway.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of priority to U.S.Provisional Patent Application No. 62/891,542, filed Aug. 26, 2019, theentire contents and disclosure of which are hereby incorporated byreference herein.

BACKGROUND OF THE DISCLOSURE A. Field of the Disclosure

The present disclosure relates generally to medical devices that areused in the human body. In particular, the present disclosure isdirected to embodiments of a closure device or occluder that includes anaccess passage and at least one closure of the access passage, andmethods of making and using the same. The embodiments and methodsdisclosed herein enable access through the occluder subsequent todeployment of the occluder within the body.

B. Background

Atrial Septal defects (ASD) include heart defects that allow blood toflow between the left and right atria of the heart, decreasing cardiacoutput. In at least some cases, ASD are closed using an occlusiveclosure device, such as the Amplatzer™ Septal Occluder (ASO). Occludersare generally formed from braided metal fabrics or wire with mesh. Someof these known occluders are shown in FIG. 1 . As illustrated,conventional occluders 50 are formed with discs 52 that engage a surfaceof the septal wall that separates the left and right atria. These discs52 can range in size from 10 mm to 54 mm in diameter and areconventionally formed of continuous metal fabric or wire. As such, thesediscs 52 form a substantially impenetrable surface, in particular forsmaller-size occluders 50.

Several percutaneous procedures, which may be performed after anoccluder has been deployed, require access to the left atrium across theseptal wall. For example, a younger patient may have an occluderdeployed to close an ASD, but may subsequently develop atrialfibrillation (AFIB). A physician may need to map and/or ablate tissue inthe left atrium, and may therefore need to cross the septal wall. Wherea conventional occluder has already been deployed, the physician may beunable to penetrate the discs (e.g., discs 52 shown in FIG. 1 ) to crossthe septal wall at the existing opening therethrough (i.e., the ASD).

Accordingly, it would be desirable to have an occlusive closure devicethat enables subsequent access for passage of medical devicestherethrough, including procedural devices and/or devices to createshunting and/or fenestrations.

Moreover, a rare, but adverse event that has been reported to occur insome occluder implantations is erosion of the atrial wall tissue. Theresult of this tissue erosion can be removing the device, fixing erodedholes and/or surgically closing defects.

Accordingly, it would be desirable to reduce or eliminate erosion ofcardiac tissue while maintaining the fundamental function andeffectiveness of an occluder.

BRIEF SUMMARY OF THE DISCLOSURE

The present disclosure generally relates to a closure device or occluderincluding an access passage. The present disclosure discloses suchdevices and methods of forming and using the same to, for example,enable access for medical devices therethrough after the closure devicehas been deployed in the human body. The occluder having the accesspassage further facilitates reducing erosion of cardiac tissue byreducing radial forces applied thereto.

In at least one aspect of the present disclosure, an occlusive medicaldevice is provided. The occlusive medical device includes a frame and atleast one closure coupled to the frame. The frame includes a distalannular flange having a radially outer surface and a radially innersurface, a proximal annular flange having a radially outer surface and aradially inner surface, and a waist portion extending between andconnecting the distal annular flange to the proximal annular flange. Theradially inner surface of the distal annular flange, the waist member,and the radially inner surface of the proximal annular flange define anunobstructed passageway through the frame. The at least one closure isconfigured to close the passageway to: (i) provide an occlusive effect,and (ii) enable subsequent access through the passageway when theocclusive medical device is deployed at a target site.

The foregoing and other aspects, features, details, utilities andadvantages of the present disclosure will be apparent from reading thefollowing description and claims, and from reviewing the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates embodiments of conventional occluders.

FIGS. 2A and 2B illustrate an exemplary embodiment of an occluderincluding an access passage sealed by an occlusive but penetrableclosure in accordance with the present disclosure.

FIG. 3 illustrates an alternative embodiment of the occluder shown inFIGS. 2A and 2B including a non-unitary frame.

FIG. 4 depicts exemplary embodiments of the position of the closure ofthe occluder.

FIGS. 5A and 5B illustrate another exemplary embodiment of the occluderof the present disclosure including an attachment point for deploymentand/or recapture of the occluder.

FIG. 6 depicts another exemplary embodiment of the occluder inaccordance with the present disclosure.

FIG. 7 depicts one exemplary embodiment of the occluder disposed withina delivery system in accordance with the present disclosure.

FIG. 8 depicts another exemplary embodiment of the occluder disposedwithin a delivery system in accordance with the present disclosure.

FIGS. 9A-9C illustrate another exemplary embodiment of the occluder inaccordance with the present disclosure, the occluder including aninternal closure.

FIG. 10 is an alternative embodiment of the occluder shown in FIGS.9A-9C.

FIG. 11 is another exemplary embodiment of an occluder including analternative frame shape in accordance with the present disclosure.

FIGS. 12A and 12B depict an alternative embodiment of the frame of theoccluder.

FIGS. 13A and 13B depict another alternative embodiment of the frame ofthe occluder.

FIGS. 14A and 14B depict an alternative embodiment of an occluderincluding an alternative frame in accordance with the presentdisclosure.

FIGS. 15A and 15B depict exemplary steps in a process of forming theoccluder shown in FIGS. 14A and 14B.

FIGS. 16A-16C illustrate deployment of the occluder shown in FIG. 15 .

FIGS. 17A and 17B illustrate an alternative embodiment of an occluderincluding an alternative frame in accordance with the presentdisclosure.

FIG. 18 illustrates the occluder shown in FIGS. 17A and 17B disposedwithin a delivery device.

FIG. 19 illustrates another embodiment of an occluder in accordance withthe present disclosure.

FIG. 20 illustrates deployment of the occluder shown in FIG. 19 .

FIG. 21 illustrates another embodiment of an occluder in accordance withthe present disclosure.

Corresponding reference characters indicate corresponding partsthroughout the several views of the drawings. It is understood that thatFigures are not necessarily to scale.

DETAILED DESCRIPTION OF THE DISCLOSURE

The present disclosure relates generally to medical devices that areused in the human body. In particular, the present disclosure generallyrelates to occluders including an access passage for access through theoccluder (e.g., by a medical device) subsequent to deployment of theoccluder within a patient's body. The occluders also include a closurethat serves an occlusion function but that is penetrable to allow accessthrough the access passage. As used herein, “access” refers broadly toaccess to and/or through the access passage by any medical deviceperforming any function. Accordingly, “access” may refer to access by amedical device such as a catheter that is passed completely through theoccluder, as well as to access by a medical device such as a deviceconfigured to create a fenestration in the occluder (e.g., a dilator,balloon, etc.).

The disclosed embodiments may lead to more consistent and improvedpatient outcomes. It is contemplated, however, that the describedfeatures and methods of the present disclosure as described herein maybe incorporated into any number of systems as would be appreciated byone of ordinary skill in the art based on the disclosure herein.

The present disclosure now will be described more fully hereinafter withreference to the accompanying drawings, in which some, but not allembodiments of the disclosure are shown. Indeed, this disclosure may beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will satisfy applicable legalrequirements. Like numbers refer to like elements throughout.

Some embodiments of the present disclosure provide a medical device,such as an occlusion device (occluder), for use in occluding anabnormality in a patient's body, such as an Atrial Septal Defect (ASD),a Ventricular Septal Defect (VSD), a Patent Ductus Arteriosus (PDA), aPatent Foramen Ovale (PFO), conditions that result from previous medicalprocedures such as Para-Valvular Leaks (PVL) following surgical valverepair or replacement, and the like. The device may also be used as aflow restrictor, pressure release device, or an aneurysm bridge or othertype of occluder for placement in the vascular system. It is understoodthat the use of the term “abnormality” is not meant to be limiting, asthe device may be configured to occlude any vessel, organ, opening,chamber, channel, hole, cavity, or the like, located anywhere in thebody.

Some embodiments of the present disclosure provide an improvedpercutaneous catheter directed intravascular occlusion device for use inthe vasculature in patients' bodies, such as blood vessels, channels,lumens, a hole through tissue, cavities, and the like, such as an ASD orVSD. Other physiologic conditions in the body occur where it is alsodesirous to occlude a vessel or other passageway to prevent blood flowinto or therethrough. These device embodiments may be used anywhere inthe vasculature where the anatomical conditions are appropriate for thedesign.

The medical device may include one or more occlusive materials, whichare configured to substantially preclude or occlude the flow of blood soas to facilitate thrombosis. As used herein, “substantially preclude orocclude flow” shall mean, functionally, that blood flow may occur for ashort time, but that the body's clotting mechanism or protein or otherbody deposits on the occlusive material results in occlusion or flowstoppage after this initial time period. According to one embodiment ofthe present disclosure, the device is configured to occlude at least aportion of a vessel, a channel, a lumen, an opening, or a cavity in lessthan about 10 minutes and even less than about 5 minutes with observedocclusions in testing as low as within about 1 minute. Thus, in oneembodiment, there is not “immediate occlusion,” as the device does notimmediately obstruct all blood flow but, rather, slows the flow of bloodin order for occlusion to occur as described above. Such immediateocclusion may result in problems in fixation or positioning of thedevice in the lumen or may result in suction or the complete stoppage offlow which may be undesirable in some circumstances.

FIGS. 2A and 2B, by way of example, illustrate an exemplary embodimentof a medical device 100 in accordance with the present disclosure. Themedical device 100 is specifically embodied as an occluder. The occluder100 includes a frame 102 and at least one closure 104. Moreparticularly, the frame 102 has an outer shape such that, when theoccluder 100 is deployed, the frame 102 conforms to the tissue (notshown in FIGS. 2A and 2B) in which the occluder 100 is deployed.

In one embodiment, the frame 102 includes two annular flanges 106, 108,specifically a left atrial or distal flange 106 and a right atrial orproximal flange 108. The annular flanges 106, 108 are connected by awaist member 110. The occluder 100 defines an open or substantially openpassageway 112 that extends through the occluder 100. Specifically, thepassageway 112 extends through the distal annular flange 106, the waistmember 110, and the proximal annular flange 108. The annular flanges106, 108 therefore have a radially outer surface 114 with an outerdiameter D_(O) and a radially inner surface 116 with an inner diameterD_(I), where the radially inner surface 116 partially defines thepassageway 112 (and generally corresponds to an inner surface 118 of thewaist member 110). In this way, annular flanges 106, 108 are considered“open,” as contrasted with closed discs (e.g., discs 52, shown in FIG. 1).

When the occluder 100 is deployed to occlude a defect (e.g., an ASD,VSD, and the like), as described further herein, the occluder 100 ispositioned within a hole in the septal wall. The distal annular flange106 is positioned on a distal side of the septal wall (i.e., within theleft atrium) and engages a distal surface of the septal wall. Theproximal annular flange 108 is positioned on a proximal side of theseptal wall (i.e., within the right atrium) and engages a proximalsurface of the septal wall. The waist member 110 extends between andconnects the annular flanges 106, 108. An outer surface of the waistmember 110 engages and conforms to a surface of the ASD. The occluder100 is radially flexible but still exerts a suitable clamping force tomaintain engagement and conformity with the local tissue, which mayreduce the risk of erosion. Each of the annular flanges 106, 108 and thewaist member 110 exhibit radial flexibility and improved conformancewith local tissue, as compared to conventional occluders.

The outer diameter D_(O) of the annular flanges 106, 108 is greater thana diameter of the ASD in which the occluder 100 is deployed, and theinner diameter D_(I) is less than the outer diameter D_(O). In someembodiments, the inner diameter D_(I) is sized such that the occluder100, specifically the passageway 112, may enable access therethrough ofdelivery devices having sizes from 4 French (Fr) to 36 Fr. It should bereadily understood that the outer diameter D_(O) and/or the innerdiameter D_(I) may vary based on the overall size of the occluder 100and/or the defect (e.g., the ASD) in which the occluder 100 is to bedeployed, which may limit the size of medical devices that may bemaneuvered through passageway 112.

In some embodiments, D_(O) is about 5 mm to about 20 mm larger thanD_(I). In some embodiments, the ratio of the area defined by theradially outer surface 114 (i.e., π*(½ D_(O))²) and the area defined bythe radially inner surface 116 (i.e., π*(½ D_(I))²) is about 2:1, suchthat the passageway 112 (partially defined by the radially inner surface116) constitutes about 50% of a surface area of a respective planar face120 defined by each annular flange 106, 108. It should be wellunderstood that the passageway 112 may constitute more or less than 50%of the surface area of this planar face, as long as the passageway 112is sufficiently sized to enable access therethrough to various medicaldevices, such as catheters. In the exemplary embodiment, the passageway112 constitutes from about 20% to about 90% of the surface area of eachannular flange 106, 108, and, more preferably, may constitute from about50% to about 70% of the surface area of each annular flange 106, 108.

By forming the frame 102 with annular flanges 106, 108 (contrasted withclosed discs, such as discs 52), the frame 102 may experience reducedradial hoop stress (e.g., due to the relative lack of rigid metalmaterial in the center thereof). As such, the occluder 100 may exertless radial force on local tissue when the occluder 100 is deployed.Accordingly, the occluder 100 may reduce the risk of erosion of thelocal tissue compared to conventional occluders. Moreover, the reductionin material in the frame 102 may reduce production cost of the occluder100.

The frame 102 may be formed from any suitable material. In at least someexemplary embodiments, the frame 102 is formed from at least one layerof braided metal material. In particular, the frame 102 is formed from ashape memory material, such as nitinol. In some embodiments, the frame102 is formed from one or multiple layers of braided nitinol wires—forexample, by folding one layer over itself to form two layers. Such amaterial may include, in some embodiments, from 36 to 288 wires. Theframe 102 may be formed from non-braided materials, including shapememory alloys. For example, a shape memory alloy may be laser-cut andheat-set, or at least one formed wire (e.g., from 1 to 50 such wires)may be wrapped about a mandrel and heat-set. In some embodiments, ahelical angle formed by the wire(s) of the frame 102 (e.g., braidedand/or wound formed wires) may be selected to optimize a hoop strengthand clamping force of the frame 102. This optimization may furtherreduce the radial force applied to local tissue when the occluder 100 isdeployed, as described above.

Alternatively, the frame 102 is formed from a non-shape memory materialand may be deployed using a balloon expander. In such embodiments, theframe 102 may be formed from cobalt, stainless steel, chromium, and/orother such medical-grade metallic materials. Alternatively, the frame102 may be formed from a polymeric material, such as plastic (e.g.,injection-molded plastic, bioabsorbable polymers or plastics, etc.). Itis contemplated that having a radiopaque (e.g., metallic, radiopaqueplastic, etc.) and/or echogenic frame may facilitate more accuratedeployment and/or subsequent identification of the location of theoccluder 100.

In the embodiment illustrated in FIGS. 2A and 2B, the frame 102 is aunitary, single-piece frame in which the annular flanges 106, 108 areintegral with the waist member 110. In such embodiments, the frame 102may be formed from a single material. In other embodiments, such as theembodiment illustrated in FIG. 3 , the annular flanges 106, 108 areformed separately from the waist member 110 and are subsequentlyattached to the waist member 110 to form the frame 102. The waist member110, in some embodiments, is the same material as the annular flanges106, 108, but in other embodiments, the waist member 110 is formed froma different material than the annular flanges 106, 108. The waist member110 may be attached to the annular flanges 106, 108 by sutures orsewing, welding, fasteners, adhesives, over-molding, insert molding,and/or any other suitable attachment method.

In the exemplary embodiment of the occluder 100, the at least oneclosure 104 is attached to the frame 102 to close or restrict access(e.g., of bodily fluids) through the passageway 112 of the occluder 100.In this way, the closure 104 ensures the occluder 100 performs itsocclusive function, as described above herein. However, the closure 104is formed from an occlusive, yet penetrable material, such that accessthrough the passageway 112 of the occluder 100 by medical devices is notrestricted. In the exemplary embodiment, a “penetrable” material is moreeasily punctured, separated, slit, pierced, or otherwise penetrated thanthe material that forms the frame 102.

In the illustrated embodiment of FIGS. 2A and 2B, the closure 104includes a first or distal closure 122 and a second or proximal closure124. The distal closure 122 is attached to the distal annular flange 106at the radially inner surface 116 thereof. Likewise, the proximalclosure 124 is attached to the proximal annular flange 108 at theradially inner surface 116 thereof. In this way, each closure 122, 124closes passageway 112.

Each closure 122, 124 is sized and shaped to substantially cover thepassageway 112 at each annular flange 106, 108. The closures 122, 124may therefore be circular and have a diameter D_(C) that is greater thanor substantially equal to the inner diameter D_(I) of the respectiveannular flange 106, 108 to which it is coupled. Closures 104 (includingclosures 122, 124), as described further herein, may have a diameterD_(C) that is substantially greater than the inner diameter D_(I). Forexample, the diameter D_(C) may be greater than or substantially equalto the outer diameter D_(O) of the respective annular flange 106, 108 towhich it is coupled. Alternatively, the closure 104 may have anon-circular shape.

In particular, FIG. 4 illustrates various sizes, shapes, and locationsof closures 104 with respect to the frame 102 of the occluder 100. Theoccluder 100 may include one, two, or three discrete closures 104. Aclosure 104 may be coupled to a flange at any location on an outersurface of the respective flange, such as adjacent the passageway 112,at the outer diameter of the flange, at some intermediate location,and/or at a surface of the flange that engages with the septal wall whenthe occluder 100 is deployed. A closure 104 may additionally oralternatively be coupled to the waist member 110 of the occluder 100 ata position intermediate the annular flanges 106, 108. A closure 104 mayadditionally or alternatively fully enclose the occluder 100.

A closure 104 is attached to the frame 102 using any suitable method,such as by suture or sewing, bonding (with other polymers, thermally,via laminating, etc.), welding, adhering, folding and/or trapping theclosure 104 within the material of the frame 102, over-molding, anycombination thereof, and/or any other suitable attachment mechanism. Inthe exemplary embodiment, therefore, the closure 104 is operable intandem with the frame 102 during deployment (including loading,advancement, and/or recapture, as described further herein) of theoccluder 100, such that the closure 104 collapses and expands as theframe 102 collapses expands.

The closure 104 may be formed from any suitable material. It iscontemplated that a bioabsorbable material that promotesendothelialization may be used to form the closure 104. After theoccluder 100 is deployed, the bioabsorbable material will be absorbedwhile tissue grows over the occluder 100. Therefore, the passageway 112will be accessible through a relatively soft, thin layer of tissue. Suchbioabsorbable materials may include polylactic acid (PLA), poly-L-lacticacid (PLLA), poly lactic-co-glycolic acid (PLGA), polycaprolactone(PCL), combinations thereof, and/or any suitable bioabsorbable material.Alternatively, the closure 104 is at least partially non-bioabsorbable,and may be formed from polyester, polyethylene terephthalate (PET),silicone, urethane, combinations thereof, other polymers, and the like.The closure 104 may, in some embodiments, be formed in part with abioabsorbable material and in part with a non-bioabsorbable material.The closure 104 may be formed from a woven, knitted, or braidedmaterial, a printed material, a molded material, and the like. Theclosure 104 may be formed from a material suitable to form afenestration therein, after the occluder 100 is deployed. For example, amedical device configured to create a fenestration (e.g., a dilator, aballoon expander, etc.) may be used to penetrate the closure 104 andcreate a fenestration therein (e.g., to enable blood flow through theoccluder 100). The closure 104 may be formed from a material that willremain open after such a procedure.

In some embodiments, the closure 104 is flexible, which may simplifydeployment of the occluder, as described further herein, and which mayimprove the penetrability of the closure 104 (contrasted with the morerigid, dense nitinol mesh that forms discs 52). In certain embodiments,however, the closure 104 may include one or more rigid reinforcementelements (not shown). These reinforcement elements may assist deploymentof the occluder 100 by ensuring proper orientation of the closure 104 asthe occluder 100 is deployed. In some such embodiments, thereinforcement elements are not bioabsorbable. In other embodiment, thereinforcement elements are bioabsorbable at a different rate than theflexible portion(s) of the closure 104.

In the illustrated embodiment, the occluder 100 also includes anattachment member 130. The attachment member 130 facilitates deploymentof the occluder 100. As described further herein, the attachment member130 is coupled to a delivery cable to advance the occluder 100 through adelivery catheter to a target location (e.g., an ASD). The attachmentmember 130 remains coupled to the delivery cable until properpositioning of the occluder 100 is confirmed. That is, the attachmentmember 130 facilitates re-positioning and/or recapture of the occluder100 during deployment. The attachment member 130 may include ascrew-like member having internal or external threads, a tether-likemember, a hoop, a hook, a ball-and-loop type coupler, and/or anysuitable attachment member 130 such that the occluder 100 isrecapturable during deployment. The attachment member 130 may be formedfrom a bioabsorbable material.

In some embodiments, the attachment member 130 is coupled to the frame102 via one or more spokes 132 extending radially inward from theradially inner surface 116 of one or more of the annular flanges 106,108. The spokes 132 may be integrally formed with the frame 102 and/ormay be attached to the frame 102 after the frame 102 is formed. In theembodiment illustrated in FIGS. 2A and 2B, the occluder 100 includesfour spokes 132. The occluder 100 may include any suitable number ofspokes 132, such as three, five, or more spokes 132. For example, in theembodiment illustrated in FIGS. 5A and 5B, the occluder 100 includesthree spokes 132. The spokes 132 in this embodiment are integral withthe frame 102 and formed from the same braided shape-alloy material ofthe frame 102. FIG. 6 illustrates a similar embodiment including fourspokes 132. Integral spokes 132 may be formed by extending portions ofthe braided material (e.g., as shown in FIGS. 5A and 5B) or, in otherembodiments, any material used to form the frame 102. Alternatively,integral spokes 132 may be formed by forming the corresponding annularflange (e.g., the proximal annular flange 108) as a fully closed disc134 of material and cutting out portions therefrom to form the spokes132 (e.g., as shown in FIG. 6 ). Although the embodiments illustrated inFIGS. 2A, 2B, and 5A-6 depict the spokes 132 positioned at the proximalangular flange 108, spokes 132 may be positioned at (e.g., extend fromor be coupled to) the distal annular flange 106 and/or the waist member110 without departing from the scope of the present disclosure.Moreover, spokes 132 may be substantially the same or may have differinglengths, shapes, orientations, and the like.

As described above, spokes 132 may be formed integrally with the frame102, as continuations of the material of frame 102, or may be coupled tothe frame 102. In some embodiments, spokes 132 may be formed from suturematerial, bio-absorbable material, and/or any suitable material. Spokes132 may assist with recapture and/or re-positioning of the occluder 100during deployment thereof. In some embodiments, the occluder 100includes a reinforcement member (not shown) coupled to the radiallyinner surface 116 of an annular flange (e.g., the proximal annularflange 108) where the spokes 132 are coupled thereto. This reinforcementmember may protect the closure 104 from the ends of the spokes 132, toprevent these ends of the spokes 132 from puncturing the closure 104.The reinforcement member may be formed from any suitable material, suchas the same material of the closure 104 (e.g., a double layer of theclosure material), or any other material.

In other embodiments, the attachment member 130 is coupled to theclosure 104. For example, the attachment member 130 may be sewn,adhered, welded, and/or otherwise attached to the closure 104. In stillother embodiments, the attachment member 130 may be formed integrallywith the closure 104. For example, where the closure 104 is formed froma molded material, the attachment member 130 may be molded (e.g., as athreaded member or a hoop). In some embodiments, where the attachmentmember 130 is not attached to the frame 102, the occluder 100 mayinclude no spokes, which may maximize the passageway 112 and enhanceaccessibility through the occluder 100 after deployment thereof.

Although the attachment member 130 is shown in a center of the occluder100 in FIGS. 2A, 2B, and 5A-6 , it should be readily understood that theattachment member 130 may be positioned in a non-central locationwithout departing from the scope of the present disclosure.

In some embodiments in which the occluder 100 includes spokes 132 on theproximal annular flange 108, a closure 104 may be coupled to thatproximal annular flange 108 via the spokes 132. For example, as shown inFIG. 6 , the spokes 132 define through-holes 136 to the passageway 112,and each through-hole 136 has a corresponding closure 104 coupledthereacross. These closures 104 are coupled to the frame 102 along thespokes 132.

Turning now to FIG. 7 , an occluder 100 in accordance with the presentdisclosure is shown within a delivery device 140. Specifically, theoccluder 100 is shown in a collapsed configuration (where the occluderis shown in an expanded or deployed configuration in FIGS. 2A-6 ) withina delivery sheath 142. A delivery cable 144 is coupled to the attachmentmember 130 such that the occluder 100 may be advanced through thedelivery sheath 142 to a target location for deployment (e.g., within anASD). A similar embodiment is shown in FIG. 8 . Specifically, theoccluder 100 is collapsed and disposed within the delivery sheath 142.In this embodiment, the attachment member 130 is recessed within theframe 102. In some embodiments, a delivery device may further include athrough-lumen or other such component that is configured to advance adistal end of the occluder 100, such as the distal annular flange 106,which may facilitate deployment and/or repositioning of the distalannular flange 106.

With reference now to FIGS. 9A-9C, another embodiment of an occluder 100is illustrated. In this embodiment, the frame 102 is formed from asingle layer of braided shape-alloy wire material (e.g., nitinol). Thebraided wire material is cut and terminated to form the frame 102 in atube or doughnut-like shape. Methods for cutting, shaping, and formingsuch braided wire frames are described in further detail inInternational Patent Application Publication No. WO2018/204106, which isincorporated herein by reference in its entirety.

In this embodiment, the closure 104 is at least partially enclosed orfolded within a pocket 150 formed by the distal annular flange 106, asdepicted in FIG. 9A. The closure 104 may be folded within the distalannular flange 106 as the frame 102 is constructed (e.g., before theframe 102 is heat-set and/or cut), such as by being temporarily coupledto the material (e.g., the cut wire ends 152) forming the distal annularflange 106 before the distal annular flange 106 is heat-set into itsfinal form. Alternatively, the closure 104 may be “installed” into thedistal annular flange 106 after the frame 102 is formed (e.g., byinserting the outer edge of the closure 104 into the pocket 150). Aseparate closure 104 may be similarly coupled to the frame 102 withinthe proximal annular flange 108. Another closure 104 may be coupled tothe frame 102 within the passageway 112 (e.g., coupled to the waistmember 110).

As shown particularly in FIGS. 9B and 9C (which are a top and bottomview, respectively, of the occluder 100), the radially inner surface 116of the annular flanges 106, 108 includes a scalloped edge including thecut wire ends 152. In some other embodiments, though not shown, at leastsome of these cut wire ends 152 may include eyelets or other attachmentmechanisms that facilitate attaching the closure 104 thereto and/or thatact as an attachment member 130 of the occluder 100 to facilitateadvancement, recapture, an/or repositioning of the occluder 100 duringdeployment thereof.

In some cases, the cut wire ends 152 of the frame 102 that form theradially inner surface 116 of the distal annular flange 106, as shown inFIGS. 9A and 9B, are exposed. To reduce a risk of thrombus from the cutwire ends 152, and to protect the cut wire ends 152 as the occluder 100is deployed, the cut wire ends 152 may be fed through the closure 104,as shown in FIG. 21 . For example, a slit 153 may be formed in theclosure 104 through which cut wire ends 152 are positioned, such thatthe cut wire ends 152 are enclosed by the closure 104. In some suchembodiments, the cut wire ends 152 may be subsequently sewn or otherwisecoupled to the closure 104 to prevent relative movement between theclosure 104 and the cut wire ends 152. The length of the cut wire ends152 to be enclosed by the closure 104 and/or the tightness of thecoupling of the cut wire ends 152 to the closure 104 may be selected toavoid interference with the ability of the frame 102 to collapse andexpand.

As shown in FIG. 9C, the proximal annular flange 108 includes threespokes 132 that are coupled to the cut wire ends 152 and extend into thepassageway 112. The attachment member 130 is coupled to the spokes 132at a central location with respect to the proximal annular flange 108.Moreover, as best seen in FIG. 9A, the spokes 132 are oriented at anoblique angle with respect to the planar surface of the proximal annularflange 108, such that the attachment member 130 is recessed into theframe 102. In this embodiment, the spokes 132 define three equally-sized“access ports” 154 to the passageway 112.

An alternative embodiment of the occluder 100 is illustrated in FIG. 10. In this embodiment, the spokes 132 have different lengths andterminate at a non-central location with respect to the proximal annularflange 108. Accordingly, the attachment member 130 is coupled to theframe 102 at this non-central location. In this embodiment, the spokes132 may interfere less with the passageway 112 by defining one accessport 156 that is substantially larger than the access ports 154 (shownin FIG. 9C).

FIG. 11 depicts another embodiment of an occluder 100 in accordance withthe present disclosure. In this embodiment, the waist member 110 formsan angle with respect to the distal annular flange 106, and the proximalannular flange 108 is not planar but concave. This alternative shape forthe waist member 110 and the proximal annular flange 108 may promoteendothelialization and/or integration into the tissue of the septalwall. One or more closures 104 may be coupled to the frame 102 at theouter surfaces of the annular flanges 106, 108 adjacent to the radiallyouter surface 114, as shown in dashed lines. Alternatively, closures 104may be coupled to the frame 102 adjacent to the radially inner surface116 of the annular flanges 106, 108, as shown in dotted lines.

Although the waist member 110 has been illustrated as conforming to theshape and/or size of the defect or tissue in which the occluder 100 isdeployed, it is contemplated that the waist member 110 may be smallerthan the defect and/or non-centrally located within the defect. Inaddition, the annular flanges 106, 108 may have alternative shapesand/or sizes than those shown herein, including irregular shapes and/orshapes that are not concentric or coaxial with the waist member 110.Moreover, the shape, size, and/or configuration of one annular flange106, 108 may differ from that of the other annular flange 106, 108.

Turning now to FIGS. 12A-13B, an alternative embodiment of a frame 202of the occluder 100 is shown. Specifically, the frame 202 is formed as alaser-cut frame (contrasted with a braided frame as previously shown).The frame 202 is first laser cut, as shown in FIGS. 12A and 12B (a sideand top view, respectively), from a nitinol tube. The ends of the tubeare then folded over to form flanges 206, 208 of the frame 202, as shownin FIGS. 13A and 13B (a side and top view, respectively). The flanges206, 208 (as well as a waist member 210) are formed from a single layerof material, which may reduce the overall profile of the occluder 100.An attachment member 130 is coupled to the ends at the proximal annularflange 208. Closures 122, 124 are coupled to the flanges 206, 208.

FIGS. 14A and 14B depict a side view and top view, respectively, ofanother occluder 100 in accordance with the present disclosure. Theoccluder 100 includes a frame 302 formed as a laser-cut frame, asdescribed above, and/or from a plurality of wound wires. In thisembodiment, annular flanges 306, 308 are formed from heat-set, curled,free wire ends. Specifically, the frame 302 may be formed as shown inFIGS. 15A and 15B. In particular, the frame 302 may include distal freewire ends 360 and proximal free wire ends 362. In some embodiments, theproximal free wire ends 362 may include attachment mechanisms 364, suchas eyelets or hooks. As shown in FIG. 15B, the free wire ends 360, 362are heat-set into curls. Closures 104 are coupled to the frame 302 atone or more longitudinal positions between annular flanges 306 and 308.For example, a distal closure 104 is coupled to the frame 302 generallyadjacent to the distal annular flange 306, and a proximal closure iscoupled to the frame 302 generally adjacent to the proximal annularflange 308.

Deployment of the occluder 100 shown in FIGS. 14A and 14B is depicted inFIGS. 16A-16C. As shown in FIG. 16A, the occluder 100 is collapsed andloaded into a delivery sheath 142. The distal free wire ends 360 may becoupled together within a delivery cap 366 to ensure they do not “curlup” within the delivery sheath 142. The delivery cap 366 is coupled to afirst delivery cable 144A. The proximal free wire ends 362 may begathered together and coupled to a second delivery cable 144B. Where theproximal free wire ends 362 include attachment mechanisms 364, thoseattachment mechanisms 364 may be engaged with the second delivery cable144B for advancement and/or recapture of the occluder 100. The first andsecond delivery cables 144A, 144B may be coupled together and/orintegral with one another.

To deploy the occluder 100 shown in FIGS. 14A and 14B, the deliverysheath 142 is maneuvered to a target location for the occluder 100(e.g., an ASD). As the occluder 100 is advanced out of the deliverysheath 142, as shown in FIG. 16B, the distal free wire ends 360 arereleased from the delivery cap 366 (e.g., by manipulating the firstdelivery cable 144A), such that the distal free wire ends 360 are freeto curl up into their heat-set configuration. The delivery sheath 142 isretracted, and the distal free wire ends 360 engage the tissue of theseptal wall to keep the occluder 100 in place. As the delivery sheath142 is retracted further, as shown in FIG. 16C, the proximal free wireends 362 are released (e.g., by manipulating the second delivery cable144B) and curl up into their heat-set configuration. Accordingly, thedistal free wire ends 360 form the distal annular flange 306, and theproximal free wire ends 362 form the proximal annular flange 308 of theoccluder 100.

One or more closures 104 may be coupled to the frame 302 as shown inFIGS. 14 and 16A-16C. In addition, in some embodiments, such as wherethe frame 302 is formed from a polymeric and/or non-radiopaque material,the occluder 100 may further include radiopaque markers 368 coupled tothe frame 302.

Yet another alternative embodiment of the occluder 100 is illustrated inFIGS. 17A and 17B (a side and top view, respectively, of the occluder100). A frame 402 of the occluder 100 is formed from one or more woundwires 470 that are continuously looped about a mandrel and heat-set.Therefore, annular flanges 406, 408 and a waist member 410 of the frame402 are defined by a plurality of loops of the wound wire(s) 470.Alternatively, as shown in FIG. 19 , a frame 402′ may include annularflanges 406′, 408′ formed from only a single loop of wound wire 470.

Closure(s) 104 are coupled to the frame 402/402′, as described aboveherein. In some such embodiments, one or more of the wires 470 may bewound into the passageway 112 to form an attachment member.Alternatively, an attachment member may be coupled to the frame 402/402′as described herein.

FIG. 18 illustrates the occluder 100 shown in FIG. 17 in a collapsedconfiguration within a delivery sheath 142. FIG. 20 illustrates theoccluder 100 shown in FIG. 19 in a partially collapsed configuration asthe occluder 100 is advanced from a delivery sheath 142 to a targetlocation (e.g., an ASD).

It should be understood that any feature of any embodiment disclosedherein may be combined with any other feature. For example, a hybridframe may include both laser-cut and braided or wound-wire featurescoupled together.

In addition, although the occluders of the present disclosure have beendescribed as being suitable for deployment within ASDs, these occludersare suitable for deployment in other tissue and/or defects, includingfor use for fenestrated ASDs, VSDs, and/or atrial shunting.

Although certain embodiments of this disclosure have been describedabove with a certain degree of particularity, those skilled in the artcould make numerous alterations to the disclosed embodiments withoutdeparting from the spirit or scope of this disclosure. All directionalreferences (e.g., upper, lower, upward, downward, left, right, leftward,rightward, top, bottom, above, below, vertical, horizontal, clockwise,and counterclockwise) are only used for identification purposes to aidthe reader's understanding of the present disclosure, and do not createlimitations, particularly as to the position, orientation, or use of thedisclosure. Joinder references (e.g., attached, coupled, connected, andthe like) are to be construed broadly and may include intermediatemembers between a connection of elements and relative movement betweenelements. As such, joinder references do not necessarily infer that twoelements are directly connected and in fixed relation to each other. Itis intended that all matter contained in the above description or shownin the accompanying drawings shall be interpreted as illustrative onlyand not limiting. Changes in detail or structure may be made withoutdeparting from the spirit of the disclosure as defined in the appendedclaims.

When introducing elements of the present disclosure or the preferredembodiment(s) thereof, the articles “a”, “an”, “the”, and “said” areintended to mean that there are one or more of the elements. The terms“comprising”, “including”, and “having” are intended to be inclusive andmean that there may be additional elements other than the listedelements.

As various changes could be made in the above constructions withoutdeparting from the scope of the disclosure, it is intended that allmatter contained in the above description or shown in the accompanyingdrawings shall be interpreted as illustrative and not in a limitingsense.

What is claimed is:
 1. An occlusive medical device comprising: a framecomprising: a distal annular flange having a radially outer surface anda radially inner surface; a proximal annular flange having a radiallyouter surface and a radially inner surface; and a waist member extendingbetween and connecting the distal annular flange to the proximal annularflange, wherein the radially inner surface of the distal annular flange,the waist member, and the radially inner surface of the proximal annularflange define an unobstructed passageway through the frame, wherein anunobstructed area of the distal annular flange delimiting the passagewayand defined by the radially inner surface of the distal annular flangerepresents between 50% and 70% of a total surface area defined by theradially outer surface of the distal annular flange, and wherein anunobstructed area of the proximal annular flange delimiting thepassageway and defined by the radially inner surface of the proximalannular flange represents between 50% and 70% of a total surface areadefined by the radially outer surface of the proximal annular flange;and at least one closure coupled to the frame and configured to closethe passageway to: (i) provide an occlusive effect, and (ii) enablesubsequent access through the passageway when the occlusive medicaldevice is deployed at a target site, wherein the at least one closure isformed from a woven, knitted, or braided material.
 2. The occlusivemedical device of claim 1, wherein the occlusive medical device isconfigured to be deployed within a septal defect (SD), wherein the waistmember conforms to a diameter of the SD, the distal annular flangeengages a left atrial surface of the SD, and the proximal annular flangeengages a right atrial surface of the SD.
 3. The occlusive medicaldevice of claim 1, wherein a diameter of the radially outer surface ofthe distal annular flange is at least 5 mm larger than a diameter of thepassageway.
 4. The occlusive medical device of claim 1, wherein theradially inner surface of the distal annular flange, the waist member,and the radially inner surface of the proximal annular flange define thepassageway to accommodate medical devices having a diameter of 4 Fr to36 Fr.
 5. The occlusive medical device of claim 1, further comprisingthree or more spokes extending radially inwardly from the radially innersurface of the proximal annular flange.
 6. The occlusive medical deviceof claim 5, further comprising an attachment member coupled to aterminal end of each of the spokes, the attachment member configured tocouple to a delivery cable for advancement and recapture of theocclusive medical device during deployment thereof.
 7. The occlusivemedical device of claim 1, wherein the frame is formed from a differentmaterial than the at least one closure.
 8. The occlusive medical deviceof claim 1, wherein the frame is formed from a shape-memory material. 9.The occlusive medical device of claim 1, wherein the frame is formedfrom one of at least one layer of braided shape-memory material, atleast one wound wire, or a laser-cut tube.
 10. The occlusive medicaldevice of claim 1, wherein the frame is formed from at least one of aradiopaque material, a metallic material, or a bioabsorbable material.11. The occlusive medical device of claim 1, wherein the frame is formedfrom a bioabsorbable material promoting tissue endothelialization. 12.The occlusive medical device of claim 1, wherein the woven, knitted, orbraided material is a non-metallic material and/or a flexible material.13. The occlusive medical device of claim 1, wherein the closure has aclosure diameter greater than a diameter of the passageway, an outeredge of the at least one closure coupled to at least one of: (i) anexterior face of the distal annular flange, (ii) an exterior face of theproximal annular flange, and (iii) an exterior surface of the waistmember.
 14. The occlusive medical device of claim 1, wherein the woven,knitted, or braided material is a bioabsorbable material promotingtissue endothelization thereon.
 15. The occlusive medical device ofclaim 1, wherein the at least one closure comprises an attachment memberconfigured to couple to a delivery cable for advancement and recaptureof the occlusive medical device during deployment thereof.
 16. Theocclusive medical device of claim 1, wherein the at least one closurecomprises a first closure coupled to the distal annular flange and asecond closure coupled to the proximal annular flange.
 17. The occlusivemedical device of claim 1, wherein the at least one closure comprises aclosure coupled to the waist member within the passageway.
 18. Theocclusive medical device of claim 1, wherein the at least one closurecomprises a closure coupled to the distal annular flange adjacent to oneof the radially inner surface of the distal annular flange or theradially outer surface of the distal annular flange.
 19. The occlusivemedical device of claim 1, wherein the at least one closure comprises aclosure coupled to the proximal annular flange adjacent to one of theradially inner surface of the proximal annular flange or the radiallyouter surface of the proximal annular flange.
 20. The occlusive medicaldevice of claim 1, wherein the at least one closure comprises a closurethat encloses the entire frame.